Independent GMP & Regulatory Compliance Auditor
Former FDA Investigator supporting pharmaceutical, medical device, and laboratory organizations with supplier audits, inspection readiness, and quality system assessments.
Over 16 years of experience across global regulated industries.
Trusted, Practical Regulatory Support
Tracey Harris is a former FDA Investigator and experienced quality and regulatory auditor with a background in pharmaceutical, biotechnology, medical device, and manufacturing environments.
Her work focuses on helping organizations assess compliance, strengthen quality systems, and prepare for regulatory inspections with practical, risk-based approaches.
Our Process
API and drug substance manufacturers
Contract manufacturers (CMOs/CDMOs)
Contract laboratories and CROs
Raw material and component suppliers
Packaging, labeling, and distribution vendors
Supplier & Vendor Audits
Mock FDA inspections
Pre-Approval Inspection (PAI) readiness
Gap assessments
Inspection strategy and preparation
FDA Inspection Readiness
Root cause analysis
Corrective action planning
Regulatory response support
Ongoing readiness improvement
Remediation
CAPA systems
Deviations and investigations
Change control
Documentation and SOP review
Data integrity assessments
Quality System Assessments
Industries Supported
How Engagements Work
01
Initial discussion to define scope and objectives
02
Audit or assessment performed onsite or remotely
03
Detailed findings, Audit report and recommendations provided
04
Optional follow-up support for remediation or readiness
Tracey ‘s Professional Background
Tracey Harris is an independent regulatory compliance expert and former FDA Investigator with over two decades of experience supporting pharmaceutical, biotechnology, and medical device organizations. Her work focuses on preparing complex manufacturing and clinical environments for high-consequence regulatory inspections, including Pre-Approval Inspections (PAIs), GMP inspections, and BIMO oversight.
She has supported organizations across advanced therapies, radiopharmaceutical manufacturing, complex API operations, and clinical research environments, providing independent assessments of systemic risk, operational readiness, and quality system effectiveness. Tracey works directly with leadership teams to align procedures, execution, and documentation, ensuring that systems perform consistently under real-world conditions.
Her approach combines regulatory insight with practical application, helping organizations move beyond temporary fixes toward sustained compliance and inspection readiness. Tracey is engaged by companies seeking experienced, independent perspective during periods of growth, regulatory preparation, or heightened operational risk.
“The mock audit went smoothly. Tracey helped identify several areas of concern and provided some feedback to improve our overall readiness for the real inspection. Tracey was very professional and engaged with our team well. It accomplished what we were hoping to get out of the exercise. Looking forward to her final summary report”
— Combination Product Manufacturer
Contact
Available for domestic and international audit engagements.
Email: Contact@traceylharris.com
Phone: (480) 382 - 8636